A Pilot Randomised Trial Comparing Short Course Infusional 5-Fluourouracil with 5-Fluorouracil and Leucovorin as Adjuvant Therapy for Resected Colorectal Carcinoma
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ABSTRACT:
DISEASE(S): Rectum,Colon
PROVIDER: 2413734 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:For surgical interventions classified as clean or clean-contaminated, including laparotomy, guidelines in human and veterinary medicine recommend a short-term perioperative antibiotic prophylaxis (PAP). In equine colic surgery, however, PAP commonly exceeds 24 h. The aim of this study was to compare a single-shot to a 5-day lasting PAP considering surgical site infections (SSI) and other adverse effects probably associated with the particular antimicrobial regimen. The study was designed as a randomised non-inferiority pilot study including horses subjected to colic surgery while receiving one of two distinct PAP regimens. All horses (n = 67) included in the study received the standard physical examination before and after surgery. Colic surgery was performed according to the current standard of the clinic. Horses were randomly assigned to two groups, receiving either the "single-shot" or the "5-day lasting" antibiotic prophylaxis. The "single-shot" group (n = 30) received penicillin and gentamicin only once before and, if needed, during surgery, whereas the "5-day lasting" group (n = 37) received antibiotics for five days. In addition to the standard laboratory examinations, serum amyloid A and fibrinogen were determined preoperatively and during five days after surgery. SSI, postoperative colitis and haemolytic anaemia were classified as postoperative complications potentially related to antibiotic use. The outcome of this preliminary non-inferiority clinical trial showed that the occurrence of postoperative adverse events (i.e., SSI, postoperative colitis and haemolytic anaemia) lacked significant differences between the study groups. Main limitations: The main limitations of this study are the limited group sizes and our inability to blind the study. Single-shot PAP seems to be an alternative approach considering the 5-day lasting protocol commonly used in equine abdominal surgery. However, a proper hygiene management together with a close clinical and laboratory monitoring of the equine patient is indispensable.
| S-EPMC8156649 | biostudies-literature
Project description:No description or hypothesis / outcomes information provided at time of study registration
| 2410830 | ecrin-mdr-crc
Project description:The optimal dosage of proton pump inhibitor in bleeding peptic ulcers remains controversial. The aim was to compare the clinical effectiveness of two doses of infusional pantoprazole in peptic ulcer bleeding.Peptic ulcer patients (n= 120) with bleeding stigmata were enrolled after successful endoscopic therapy. After an initial bolus injection of 80 mg pantoprazole, patients were randomized to receive continuously infused pantoprazole at either 192 mg day(-1) or 40 mg every 6 h (i.e. 160 mg day(-1)) for 3 days. Clinical outcomes between the two groups within 14 days were compared, with 14-day recurrent bleeding regarded as the primary end-point.Both groups (n= 60 each) were well matched in demographic and clinical factors upon entry. Bleeding totally recurred in 11 (9.2%) patients, with six (10%) in the 192 mg day(-1) group and five (8.3%) in the 160 mg day(-1) group (relative risk of bleeding recurrence between two treatments 1.2; 95% CI 0.39, 3.72). All secondary outcomes between the two groups were similar, including the amount of blood transfusion (mean 1179 ml vs. 1203 ml, P > 0.1), hospital stay (mean 9.5 days vs. 9.9 days, P > 0.1), need for surgery (n= 1 vs. n= 0, P > 0.1), and mortality (n= 1 vs. n= 0, P > 0.1).Following endoscopic haemostasis, infusional pantoprazole at either 192 mg day(-1) or 40 mg every 6 h appear similar.
| S-EPMC2829694 | biostudies-literature
Project description:Background:The recommended duration of antibiotic treatment for Enterobacteriaceae bloodstream infections is 7-14 days. We compared the outcomes of patients receiving short-course (6-10 days) vs prolonged-course (11-16 days) antibiotic therapy for Enterobacteriaceae bacteremia. Methods:A retrospective cohort study was conducted at 3 medical centers and included patients with monomicrobial Enterobacteriaceae bacteremia treated with in vitro active therapy in the range of 6-16 days between 2008 and 2014. 1:1 nearest neighbor propensity score matching without replacement was performed prior to regression analysis to estimate the risk of all-cause mortality within 30 days after the end of antibiotic treatment comparing patients in the 2 treatment groups. Secondary outcomes included recurrent bloodstream infections, Clostridium difficile infections (CDI), and the emergence of multidrug-resistant gram-negative (MDRGN) bacteria, all within 30 days after the end of antibiotic therapy. Results:There were 385 well-balanced matched pairs. The median duration of therapy in the short-course group and prolonged-course group was 8 days (interquartile range [IQR], 7-9 days) and 15 days (IQR, 13-15 days), respectively. No difference in mortality between the treatment groups was observed (adjusted hazard ratio [aHR], 1.00; 95% confidence interval [CI], .62-1.63). The odds of recurrent bloodstream infections and CDI were also similar. There was a trend toward a protective effect of short-course antibiotic therapy on the emergence of MDRGN bacteria (odds ratio, 0.59; 95% CI, .32-1.09; P = .09). Conclusions:Short courses of antibiotic therapy yield similar clinical outcomes as prolonged courses of antibiotic therapy for Enterobacteriaceae bacteremia, and may protect against subsequent MDRGN bacteria.
| S-EPMC5849997 | biostudies-literature
Project description:BackgroundEnding the global tuberculosis (TB) epidemic requires a focus on treating individuals with latent TB infection (LTBI) to prevent future cases. Promising trials of shorter regimens have shown them to be effective as preventative TB treatment, however there is a paucity of data on self-administered treatment completion rates. This pilot trial assessed treatment completion, adherence, safety and the feasibility of treating LTBI in the UK using a weekly rifapentine and isoniazid regimen versus daily rifampicin and isoniazid, both self-administered for 12 weeks.MethodsAn open label, randomised, multi-site pilot trial was conducted in London, UK, between March 2015 and January 2017. Adults between 16 and 65?years with LTBI at two TB clinics who were eligible for and agreed to preventative therapy were consented and randomised 1:1 to receive either a weekly combination of rifapentine/isoniazid ('intervention') or a daily combination of rifampicin/isoniazid ('standard'), with both regimens taken for twelve weeks; treatment was self-administered in both arms. The primary outcome, completion of treatment, was self-reported, defined as taking more than 90% of prescribed doses and corroborated by pill counts and urine testing. Adverse events were recorded.ResultsFifty-two patients were successfully enrolled. In the intervention arm 21 of 27 patients completed treatment (77.8, 95% confidence interval [CI] 57.7-91.4), compared with 19 of 25 (76.0%, CI 54.9-90.6) in the standard of care arm. There was a similar adverse effect profile between the two arms.ConclusionIn this pilot trial, treatment completion was comparable between the weekly rifapentine/isoniazid and the daily rifampicin/isoniazid regimens. Additionally, the adverse event profile was similar between the two arms. We conclude that it is safe and feasible to undertake a fully powered trial to determine whether self-administered weekly treatment is superior/non-inferior compared to current treatment.Trial registrationThe trial was funded by the NIHR, UK and registered with ISRCTN ( 26/02/2013-No.04379941 ).
| S-EPMC7818935 | biostudies-literature
Project description:ObjectivesEvidence on the clinical performance of recently introduced dental implants in titanium-zirconium alloy is sparse. The aim of the present pilot study with randomized controlled design is to compare changes in supporting structures around dental titanium-zirconium alloy implants to commercially pure titanium implants.Material and methodsThe present material includes consecutive patients referred to a specialist clinic in Sweden. Two patient groups treated with dental implants in two different materials - titanium (Ti) and titanium-zirconium (TiZr) - were defined after block randomisation for smoking. In total, 40 implants installed in 21 patients were available for one-year follow-up. Marginal bone level, soft tissue height and width of keratinised mucosa were registered at baseline and at one-year follow-up.ResultsAt implant level, the test group (TiZr) yielded significant marginal bone loss (P < 0.001) after one year. Additionally, marginal bone loss after one year was significantly higher for TiZr implants (P < 0.001) as compared to traditional Ti implants. Soft tissue dimensions were stable throughout the evaluation time for both implant materials.ConclusionsOne-year results indicate more pronounced initial marginal bone loss for dental implants in titanium-zirconium alloy as compared to implants made of commercially pure titanium.
| S-EPMC7875101 | biostudies-literature
Project description:OBJECTIVE:The immune modulatory drug chloroquine (CQ) has been demonstrated to enhance survival following radiotherapy in patients with high-grade glioma in a clinical trial, but the efficacy in patients with brain metastases is unknown. We hypothesized that short-course CQ during whole brain radiotherapy (WBRT) would improve response to local therapy in patients with brain metastases. METHODS:A prospective, single-cohort study was performed combining WBRT with concurrent CQ to assess both the feasibility of and intracranial response to combined therapy in patients with brain metastases. Safety, tolerability and overall survival of this combination was also examined, along with allelic status of IDO2 (indoleamine 2,3-dioxygenase 2), an immune modulatory enzyme inhibited by chloroquine that may affect survival outcomes. CQ therapy (250 mg by mouth daily) was initiated 1 week before WBRT (37.5 Gy in 2.5 Gy daily fractions) in patients with newly diagnosed brain metastases from biopsy-proven, primary lung, breast or ovarian solid tumors (n=20). The primary endpoint was radiologic response 3 months after combined CQ and WBRT therapy. Secondary endpoints included toxicity and overall survival. Patients were stratified by IDO2 allelic status. RESULTS:After a median clinical follow up of 5 months (range, 0.5-31), 16 patients were evaluable for radiologic response which was complete response in two patients, partial response in 13 patients and stable disease in one patient. There were no treatment-related grade?3 toxicities or treatment interruption due to toxicity. Median and mean overall survival was 5.7 and 8.9 months, respectively (range, 0.8-31). A trend toward increased overall survival was observed in patients with wild-type IDO2 compared to patients with heterozygous or homozygous configurations that ablate IDO2 enzyme activity (10.4 mos vs. 4.1 mos.; p=0.07). CONCLUSIONS:WBRT with concurrent, short-course CQ is well tolerated in patients with brain metastases. The high intracranial disease control rate warrants additional study.
| S-EPMC3810973 | biostudies-literature